[Congressional Record Volume 154, Number 155 (Saturday, September 27, 2008)]
[House]
[Pages H10170-H10176]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




              QI PROGRAM SUPPLEMENTAL FUNDING ACT OF 2008

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
Senate bill (S. 3560) to amend title XIX of the Social Security Act to 
provide additional funds for the qualifying individual (QI) program, 
and for other purposes.
  The Clerk read the title of the Senate bill.
  The text of the Senate bill is as follows:

                                S. 3560

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``QI Program Supplemental 
     Funding Act of 2008''.

     SEC. 2. FUNDING FOR THE QUALIFYING INDIVIDUAL (QI) PROGRAM.

       Section 1933(g)(2) of the Social Security Act (42 U.S.C. 
     1396u-3(g)(2)), as amended by section 111(b) of the Medicare 
     Improvements for Patients and Providers Act of 2008 (Public 
     Law 110-275), is amended--
       (1) in subparagraph (I), by striking ``$300,000,000'' and 
     inserting ``$315,000,000''; and
       (2) in subparagraph (J), by striking ``$100,000,000'' and 
     inserting ``$130,000,000''.

     SEC. 3. MANDATORY USE OF STATE PUBLIC ASSISTANCE REPORTING 
                   INFORMATION SYSTEM (PARIS) PROJECT.

       (a) In General.--Section 1903(r) of the Social Security Act 
     (42 U.S.C. 1396b(r)) is amended--
       (1) in paragraph (1), in the matter preceding subparagraph 
     (A), by inserting ``, in addition to meeting the requirements 
     of paragraph (3),'' after ``a State must''; and
       (2) by adding at the end the following new paragraph:
       ``(3) In order to meet the requirements of this paragraph, 
     a State must have in operation an eligibility determination 
     system which provides for data matching through the Public 
     Assistance Reporting Information System (PARIS) facilitated 
     by the Secretary (or any successor system), including 
     matching with medical assistance programs operated by other 
     States.''.
       (b) Effective Date.--
       (1) In general.--Except as provided in paragraph (2), the 
     amendments made by subsection (a) take effect on October 1, 
     2009.
       (2) Extension of effective date for state law amendment.--
     In the case of a State plan under title XIX of the Social 
     Security Act (42 U.S.C. 1396 et seq.) which the Secretary of 
     Health and Human Services determines requires State 
     legislation in order for the plan to meet the additional 
     requirements imposed by the amendments made by subsection 
     (a), the State plan shall not be regarded as failing to 
     comply with the requirements of such title solely on the 
     basis of its failure to meet these additional requirements 
     before the first day of the first calendar quarter beginning 
     after the close of the first regular session of the State 
     legislature that begins after the date of enactment of this 
     Act. For purposes of the previous sentence, in the case of a 
     State that has a 2-year legislative session, each year of the 
     session is considered to be a separate regular session of the 
     State legislature.

     SEC. 4. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, 
                   CERTAIN ANTIBIOTICS.

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
     the following:
       ``(v) Antibiotic Drugs Submitted Before November 21, 
     1997.--
       ``(1) Antibiotic drugs approved before november 21, 1997.--
       ``(A) In general.--Notwithstanding any provision of the 
     Food and Drug Administration Modernization Act of 1997 or any 
     other provision of law, a sponsor of a drug that is the 
     subject of an application described in subparagraph (B)(i) 
     shall be eligible for, with respect to the drug, the 3-year 
     exclusivity period referred to under clauses (iii) and (iv) 
     of subsection (c)(3)(E) and under clauses (iii) and (iv) of 
     subsection (j)(5)(F), subject to the requirements of such 
     clauses, as applicable.
       ``(B) Application; antibiotic drug described.--
       ``(i) Application.--An application described in this clause 
     is an application for marketing submitted under this section 
     after the date of the enactment of this subsection in which 
     the drug that is the subject of the application contains an 
     antibiotic drug described in clause (ii).
       ``(ii) Antibiotic drug.--An antibiotic drug described in 
     this clause is an antibiotic drug that was the subject of an 
     application approved by the Secretary under section 507 of 
     this Act (as in effect before November 21, 1997).
       ``(2) Antibiotic drugs submitted before november 21, 1997, 
     but not approved.--
       ``(A) In general.--Notwithstanding any provision of the 
     Food and Drug Administration Modernization Act of 1997 or any 
     other provision of law, a sponsor of a drug that is the 
     subject of an application described in subparagraph (B)(i) 
     may elect to be eligible for, with respect to the drug--
       ``(i)(I) the 3-year exclusivity period referred to under 
     clauses (iii) and (iv) of subsection (c)(3)(E) and under 
     clauses (iii) and (iv) of subsection (j)(5)(F), subject to 
     the requirements of such clauses, as applicable; and
       ``(II) the 5-year exclusivity period referred to under 
     clause (ii) of subsection (c)(3)(E) and under clause (ii) of 
     subsection (j)(5)(F), subject to the requirements of such 
     clauses, as applicable; or
       ``(ii) a patent term extension under section 156 of title 
     35, United States Code, subject to the requirements of such 
     section.
       ``(B) Application; antibiotic drug described.--
       ``(i) Application.--An application described in this clause 
     is an application for marketing submitted under this section 
     after the date of the enactment of this subsection in which 
     the drug that is the subject of the application contains an 
     antibiotic drug described in clause (ii).
       ``(ii) Antibiotic drug.--An antibiotic drug described in 
     this clause is an antibiotic drug that was the subject of 1 
     or more applications received by the Secretary under section 
     507 of this Act (as in effect before November 21, 1997), none 
     of which was approved by the Secretary under such section.
       ``(3) Limitations.--
       ``(A) Exclusivities and extensions.--Paragraphs (1)(A) and 
     (2)(A) shall not be construed to entitle a drug that is the 
     subject of an approved application described in subparagraphs 
     (1)(B)(i) or (2)(B)(i), as applicable, to any market 
     exclusivities or patent extensions other than those 
     exclusivities or extensions described in paragraph (1)(A) or 
     (2)(A).
       ``(B) Conditions of use.--Paragraphs (1)(A) and (2)(A)(i) 
     shall not apply to any condition of use for which the drug 
     referred to in subparagraph (1)(B)(i) or (2)(B)(i), as 
     applicable, was approved before the date of the enactment of 
     this subsection.
       ``(4) Application of certain provisions.--Notwithstanding 
     section 125, or any other provision, of the Food and Drug 
     Administration Modernization Act of 1997, or any other 
     provision of law, and subject to the limitations in 
     paragraphs (1), (2), and (3), the provisions of the Drug 
     Price Competition and Patent Term Restoration Act of 1984 
     shall apply to any drug subject to paragraph (1) or any drug 
     with respect to which an election is made under paragraph 
     (2)(A).''.
       (b) Transitional Rules.--
       (1) With respect to a patent issued on or before the date 
     of the enactment of this Act, any patent information required 
     to be filed with the Secretary of Health and Human Services 
     under subsection (b)(1) or (c)(2) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) to be 
     listed on a drug to which subsection (v)(1) of such section 
     505 (as added by this section) applies shall be filed with 
     the Secretary not later than 60 days after the date of the 
     enactment of this Act.
       (2) With respect to any patent information referred to in 
     paragraph (1) of this subsection that is filed with the 
     Secretary within the 60-day period after the date of the 
     enactment of this Act, the Secretary shall publish such 
     information in the electronic version of the list referred to 
     at section 505(j)(7) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 355(j)(7)) as soon as it is received, but in 
     no event later than the date that is 90 days after the 
     enactment of this Act.
       (3) With respect to any patent information referred to in 
     paragraph (1) that is filed with the Secretary within the 60-
     day period after the date of enactment of this Act, each 
     applicant that, not later than 120 days after the date of the 
     enactment of this Act, amends an application that is, on or 
     before the date of the enactment of this Act, a substantially 
     complete application (as defined in paragraph (5)(B)(iv) of 
     section 505(j) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j))) to contain a certification described in 
     paragraph (2)(A)(vii)(IV) of such section 505(j) with respect 
     to that patent shall be deemed to be a first applicant (as 
     defined in paragraph (5)(B)(iv) of such section 505(j)).

     SEC. 5. CLARIFICATION OF AUTHORITY FOR USE OF MEDICAID 
                   INTEGRITY PROGRAM FUNDS.

       (a) Clarification of Authority for Use of Funds.--
       (1) In general.--Section 1936 of the Social Security Act 
     (42 U.S.C. 1396u-6) is amended--
       (A) in subsection (b)(4), by striking ``Education of'' and 
     inserting ``Education or training, including at such 
     national, State, or regional conferences as the Secretary may 
     establish, of State or local officers, employees, or 
     independent contractors responsible for the administration or 
     the supervision of the administration of the State plan under 
     this title,''; and
       (B) in subsection (e), by striking paragraph (2) and 
     inserting the following:
       ``(2) Availability; authority for use of funds.--
       ``(A) Availability.--Amounts appropriated pursuant to 
     paragraph (1) shall remain available until expended.

[[Page H10171]]

       ``(B) Authority for use of funds for transportation and 
     travel expenses for attendees at education, training, or 
     consultative activities.--
       ``(i) In general.--The Secretary may use amounts 
     appropriated pursuant to paragraph (1) to pay for 
     transportation and the travel expenses, including per diem in 
     lieu of subsistence, at rates authorized for employees of 
     agencies under subchapter I of chapter 57 of title 5, United 
     States Code, while away from their homes or regular places of 
     business, of individuals described in subsection (b)(4) who 
     attend education, training, or consultative activities 
     conducted under the authority of that subsection.''.
       (2) Effective date.--The amendments made by paragraph (1) 
     shall take effect as if included in the enactment of section 
     1936 of the Social Security Act, as added by section 6034(a) 
     of the Deficit Reduction Act of 2005 (Public Law 109-171).
       (b) Public Disclosure.--
       (1) In general.--Section 1936(e)(2)(B) of such Act (42 
     U.S.C. 1396u-6(e)(2)(B)), as added by subsection (a) of this 
     section, is amended by adding at the end the following:
       ``(ii) Public disclosure.--The Secretary shall make 
     available on a website of the Centers for Medicare & Medicaid 
     Services that is accessible to the public--

       ``(I) the total amount of funds expended for each 
     conference conducted under the authority of subsection 
     (b)(4); and
       ``(II) the amount of funds expended for each such 
     conference that were for transportation and for travel 
     expenses.''.

       (2) Effective date.--The amendment made by paragraph (1) 
     shall apply to conferences conducted under the authority of 
     section 1936(b)(4) of the Social Security Act (42 U.S.C. 
     1396u-6(b)(4)) after the date of enactment of this Act.

     SEC. 6. FUNDING FOR THE MEDICARE IMPROVEMENT FUND.

       Section 1898(b)(1) of the Social Security Act (42 U.S.C. 
     1395iii(b)(1)) is amended by striking ``$2,220,000,000'' and 
     inserting ``$2,290,000,000''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Oklahoma (Mr. Sullivan) 
each will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker I ask unanimous consent that all Members may 
have 5 legislative days to revise and extend their remarks and include 
extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in strong support of S. 3560, the QI Program 
Supplemental Funding Act of 2008, introduced by my Senate colleague, 
Senator Max Baucus. 
  Mr. Speaker, this bill makes a number of technical, but important, 
changes that will improve the Medicare and Medicaid programs. This 
legislation also contains an important provision that will help 
incentivize the development of new antibiotics.
  Earlier this summer, Congress passed H.R. 6331, the Medicare 
Improvements for Patients and Providers Act of 2008, which extended the 
Qualifying Individual, or QI, program to December of 2009. The QI 
program provides important financial assistance to low-income Medicare 
beneficiaries.
  Unfortunately, when we passed H.R. 6331, we did not include enough 
money in the QI program to fully cover the level of need. We need an 
additional $45 million in order to fully cover the cost of the program 
through the end of next year. Otherwise, vulnerable Medicare 
beneficiaries may be disenrolled and lose access to important health 
services, and we certainly can't allow this to happen.
  Mr. Speaker, this legislation also contains a provision that would 
encourage and incentivize drug manufacturers to research and develop 
antibiotics. Presently, there's too little research being done to 
develop new and innovative antibiotics therapies. That is particularly 
troubling at a time when antibiotic resistance is a growing problem.
  According to the Infectious Disease Society of America, about 2 
million people acquire bacterial infections in U.S. hospitals each 
year, and 90,000 die as a result. Approximately 70 percent of these 
infections are resistant to at least one drug.
  Mr. Speaker, the R&D pipeline for antibiotics is drying up. Major 
pharmaceutical companies simply are not investing in the development of 
new antibiotics because it's not as profitable as drugs that treat 
chronic conditions. This is an important provision that I believe will 
help reverse that trend and lead to new breakthroughs and help protect 
the public health.
  Mr. Speaker, in addition to these two provisions, the bill before us 
contains several other technical changes that would improve the 
Medicare and Medicaid programs and generate savings.
  I urge my colleagues on both sides of the aisle to support this 
legislation.
  I reserve the balance of my time.
  Mr. SULLIVAN. Mr. Speaker, I rise in support of S. 3560. The bill is 
designed to make technical corrections to policies we enacted in this 
and previous Congresses.
  Specifically, this bill, at its core, corrects a technical error in 
the funding level for the extension of the QI-1 program that was passed 
earlier this year as part of the Medicare Improvements for Patients and 
Providers Act of 2008. The QI-1 program provides for the government's 
payment of Medicare part B premiums for certain low-income 
beneficiaries through the State Medicaid program.
  In addition, this bill provides an important correction in FDA policy 
regarding the development of antibiotics. This provision would have 
been in the Food and Drug Administration Amendments Act that we passed 
last year; however, it was dropped at the last minute because of PAYGO 
reasons.
  Finally, this bill provides the Secretary with additional authority 
to perform education and outreach activities as part of the Medicaid 
Integrity Program established by the Deficit Reduction Act of 2005.
  This bill is fully paid for, with some money left over to spare. The 
offset for this bill is the use of the State Public Assistance 
Reporting Information System. This system provides States with a tool 
to improve program integrity and go after fraud and abuse in the 
administration of public and medical assistance programs. This system 
does this by matching program enrollment data, such as Medicaid 
enrollment data, with data from other States which determine possible 
duplicate payments.
  Mr. Speaker, I urge Members to support this legislation. However, I 
do want to remind Members that the need for a technical bill might not 
have arisen if the majority would have involved the minority in the 
crafting of the Medicare bill passed in July. The majority should have 
provided the minority time to review the legislation and offer a motion 
to recommit.
  I support this legislation, but I hope moving forward the majority 
will include the minority when writing major legislation.
  I yield as much time as the gentleman may consume to my friend from 
Michigan, Dave Camp.
  Mr. CAMP of Michigan. Mr. Speaker, I thank the gentleman for 
yielding, and I'm also pleased to rise in support of this legislation, 
which will make important changes to the Qualified Individual program.
  This program helps low-income Medicare beneficiaries pay for their 
Medicare premiums. While the QI program was extended under the Medicare 
Improvement for Patients and Providers Act enacted in July, some States 
were still facing shortfalls.
  The bill we are debating today provides $45 million to ensure States 
like Alabama and South Carolina have sufficient funds to maintain 
Medicare enrollment for their low-income seniors. Importantly, this 
bill is fully paid for by requiring State Medicaid programs to 
electronically submit eligibility determinations to the Public 
Assistance Reporting Information System.
  Mr. Speaker, it is critical to the health of low-income seniors that 
we enact this legislation promptly, and I urge the House to support 
this bill.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from 
California, the chairman of the Ways and Means Health Subcommittee, Mr. 
Stark.
  (Mr. STARK asked and was given permission to revise and extend his 
remarks.)
  Mr. STARK. Mr. Speaker, my remarks shall be brief, because the 
distinguished ranking member of the Subcommittee on Health on the 
Committee on Ways and Means was participating and is so adequately up 
on this bill that he just said it all. I would associate myself with 
the remarks of the

[[Page H10172]]

distinguished gentleman from Michigan.
  I rise in support of the QI Program Supplemental Funding Act, S. 
3560.
  At nearly $100 a month, the Part B premium can be a real hardship for 
seniors living on low incomes.
  This bill is necessary to ensure that low-income Medicare 
beneficiaries with annual incomes between $12,000-$14,000 are able to 
continue receiving financial assistance for the cost of their Medicare 
premiums.
  I support extending this vital program. If this bill doesn't pass, 
States will drop poor seniors from the program.
  My only complaint is that we should be doing more than this today. We 
have technical corrections from the Medicare legislation we passed 
earlier this year which should be before us as part of this 
legislation. Unfortunately, the Senate failed to reach agreement to 
incorporate those needed provisions in this bill.
  There is much we need to do to maintain our commitment to Medicare 
and Medicaid. This bill is a tiny part of that work. I look forward to 
continuing to work with my colleagues on both sides of the aisle--and 
on both sides of the Capitol--to do much more.
  Mr. SULLIVAN. Mr. Speaker, I yield to the gentleman from Virginia, 
Congressman Wolf, as much time as he may consume.
  (Mr. WOLF asked and was given permission to revise and extend his 
remarks.)
  Mr. WOLF. I was watching this meeting and resolution in my office 
today, and I support it. I think it's a good issue, but I want to say 
to the gentleman from New Jersey, I don't understand why you've boxed 
up for months and years the bill that Congressman Chris Smith has that 
deals with Lyme disease.
  I was at a national Lyme disease conference this week. Lyme disease 
is spreading through our Nation. Lyme disease is spreading through my 
congressional district. Lyme disease is spreading through New Jersey, 
spreading through the gentleman's district, spreading through Mr. 
Smith's district, and if I could get the gentleman's attention, rather 
than whispering back and forth, I would like to know, if we are going 
to do resolutions like this and take them out of the committee, why Mr. 
Smith's bill, which has been pending in your committee for a long time, 
cannot be considered?
  If you watched the movie the other day, the number of people that 
have been impacted by Lyme disease is very serious. This is spreading. 
It's in Pennsylvania, I would tell the person who's chairing the House. 
It is spreading throughout the United States, and yet the bill is boxed 
up, locked up in your committee, and I want to know, because I've had 
enough of seeing this thing and seeing it go time after time after 
time, and you're keeping the bill from coming out.
  So if I could yield to the gentleman to tell me, what do you plan on 
doing about Lyme disease? Why won't you get that bill out? What is the 
status of it? And what would we tell somebody who happens to have Lyme 
disease today to know that the bill is pending in the committee?
  I yield to the gentleman.
  Mr. PALLONE. Well, as I've discussed with the gentleman, because we 
have actually talked about this on several occasions, I believe we are 
now doing what we call consent bills, in other words, bills that have 
the consent, meaning are basically agreed to not only by the Democrats 
and Republicans, but also by the members of the subcommittee and the 
Members of the House in general, because as you know, you have to have 
a two-thirds vote to pass these bills or do them by unanimous consent.
  We do not have anything near consensus on that legislation. It would 
have to go through regular order, have a hearing, go through 
subcommittee. The problem is that many, probably the majority, but I 
won't venture to say whether it's majority or minority, but many people 
do not agree with the protocol, if you will, that is suggested, if not 
mandated, by that legislation.
  In other words, right now, the majority of the doctors treat Lyme 
disease, you know, in a certain fashion. Those who advocate for that 
legislation suggest a different protocol, and frankly, I have tried 
very hard as chairman of the Health Subcommittee not to mandate or make 
decisions for physicians as to what kind of protocols they use. In this 
case, the protocol is very different from the overwhelming majority of 
the doctors, and so it's a very controversial issue that needs to have 
a lot of debate.
  So there's absolutely no way that we could do something like that on 
a consent calendar because many of the Members simply don't support it.
  Mr. WOLF. Reclaiming my time, why hasn't the gentleman had hearings 
on it?
  Mr. PALLONE. Well, we could certainly have hearings on it, and as I 
discussed with the gentleman, I would like to have hearings not only on 
that bill but on the issue of Lyme disease, research and treatment, and 
we will certainly do that in the next session. But we're obviously not 
doing this today in the context of a consent calendar.
  Mr. WOLF. Reclaiming my time, I will take you at your word that 
you're going to have hearings, is that accurate, early in the year?
  Mr. PALLONE. What I said is I would like to have hearings on the 
issue related to Lyme. We can certainly take up the issues that are 
raised in that legislation in the context of that, but as I would say 
to the gentleman again, the protocol in that legislation is very 
controversial. It's certainly one of the many things that we would have 
to consider in the context of research and treatment of Lyme disease.
  Mr. WOLF. Reclaiming my time, we're not going to let this issue go 
away, I want to tell the gentleman from New Jersey, even if I have to 
come up into New Jersey and go throughout to say that this bill is 
being boxed up.
  Just so Members know, instances of Lyme disease are rapidly rising in 
Virginia, not only in my congressional district but across the country. 
According to the Centers for Disease Control and Prevention, from 1993 
to 2007, reported cases of Lyme in Virginia have risen 990 percent, and 
this committee has done nothing. In the same time frame, reported cases 
are up 235 percent nationwide.
  Lyme disease is frightening, keeps the Boy Scouts and Girl Scouts 
from camping during summer months or children playing in the backyard 
or joggers on bike paths through tree-lined neighborhoods, sharing the 
outdoors with a minute insect that can bring monumental health 
problems.
  Congress needs to get serious. I was watching this and I think you 
have boxed it up. You know, when the gentleman was speaking--if you 
could look at me, I would just appreciate it. I want to tell the 
gentleman that we're going to hold you to this with regard to hearings. 
I will come and testify, but if this issue is boxed up next year, we're 
going to deal with it in many ways.

                              {time}  1330

  I would ask unanimous consent--if you want to say something, I'll 
wait.
  Mr. PALLONE. Well, I would just say this: You know, it does bother me 
because the gentleman is sort of suggesting that you and I haven't had 
conversations about this. We've actually had many conversations about 
this. I've told you the same thing I've just said here on the floor. 
And I really don't understand why the gentleman is giving the 
impression that somehow we haven't discussed this because we have.
  Mr. WOLF. Reclaiming my time, I never said--we've discussed it twice. 
What I'm saying is that you've boxed the bill up, you've boxed Chris 
Smith's bill up. You've held no hearings. And there are a lot of people 
around the country that are suffering with Lyme disease. And you appear 
to be the rail block. And so what we're asking for is hearings, and 
give us an opportunity for all people of all sides to be heard.
  Mr. PALLONE. Would the gentleman yield?
  Mr. WOLF. I would yield.
  Mr. PALLONE. First of all, I resent the fact that the gentleman is 
suggesting that we ``boxed this up.'' I would point out to the 
gentleman that the problem of Lyme disease has been around for many 
years. And the gentleman and his committee, Appropriations Committee, 
were in the majority for, what, at least 12 years before the last 2 
years that the Democrats have been in the majority? Certainly, the 
gentleman had plenty of opportunity, and still does, to do something 
about this himself.
  Mr. WOLF. Reclaiming my time, I was going to offer the Chris Smith 
amendment to the appropriations bill.

[[Page H10173]]

The Appropriations Committee hasn't met and had any hearings for 
months. Your side has prohibited any amendments from being offered. But 
I will tell the gentleman, next year, if you don't move this bill, I am 
going to offer it to the Labor-H bill next year and we will have to 
deal with it on the floor.
  I believe we have a responsibility to address an issue that is 
wreaking havoc in my district and across the country. That's the rapid 
rise in Lyme disease and there is a bill pending in the Energy and 
Commerce Health Subcommittee that could go a long way towards helping 
raise awareness about the threat of Lyme.
  Just this week I went to a briefing sponsored by the National Capital 
Lyme and Tick-Borne Disease Association. People are suffering from 
Bell's palsy, meningitis and other manifestations from Lyme disease.
  There are people in my district whose entire nuclear family suffers 
from chronic Lyme: Young men and women who have had to take medical 
leave from their college studies to battle severe joint pain and 
bleeding ulcers, once healthy people unable to dress themselves or tie 
their shoes; and folks hundreds of thousands of dollars in debt just 
trying to get some quality of life back for their loved ones.
  Americans need to learn about Lyme and press their Federal legislator 
to act. It is unacceptable--an outrage--for Congress to ignore this 
issue.
  This past August I held a Lyme disease awareness forum in my district 
in Loudoun County, Virginia, to help my constituents learn how to 
prevent Lyme disease from touching their families. Three medical 
doctors, including two county health departments, volunteered their 
time to share their expertise in Lyme-related issues.
  Lyme disease is an illness caused by bacteria that are transmitted to 
people by the bite of an infected black-legged tick, also known as the 
deer tick, which is comparable in size to the tip of a ball point pen. 
With all of the natural beauty and outdoor activities in many of the 
congressional districts we represent, it's important we work to educate 
our constituents about this debilitating disease.
  Speaking as a father of five and grandfather of 13, I worry about 
deer, mice, and even family pets transporting ticks and transmitting 
Lyme.
  Incidents of Lyme disease are rising rapidly in Virginia and across 
the country. According to the Centers for disease Control and 
Prevention, from 1993 to 2007 reported cases of Lyme in Virginia have 
risen 909 percent. In that same time frame, reported cases are up 235 
percent nationwide.
  Lyme disease is frightening. Picture Boy Scouts and Girl Scouts 
camping during the summer months or children playing in the backyard, 
or joggers on bike paths through tree-lined neighborhoods--sharing the 
outdoors with a minute insect that can bring monumental health 
problems.
  This Congress needs to get serious about stepping up to the plate, 
and making sure people in high risk areas are aware of this threat. 
H.R. 741--The Lyme and Tick-Borne disease Prevention, Education, and 
Research Act--legislation introduced by Chris Smith with a host of 
original cosponsors from New York, Connecticut, Arizona, Illinois, 
Rhode Island, Washington, among others, now has collected well over 100 
bipartisan cosponsors.
  The bill, which would expand Federal efforts with respect to 
prevention, education, and research activities, will go a long way 
toward getting the word out about Lyme disease and the precautions 
people can take to ensure that they never have to suffer the 
consequences of chronic Lyme.
  ``An ounce of prevention is worth a pound of cure'' could not be a 
more appropriate adage for Lyme disease. Failure to recognize Lyme 
disease early in its course can result in the development of difficult 
to treat infections in the brain, eyes, joints, heart, and elsewhere in 
the body.
  As public servants, we have given our word to do everything we can to 
protect the public interest. We are sorely lacking in Federal efforts 
to increase awareness and education about Lyme disease. Every year 
since 1998, legislation similar to H.R. 741 has been introduced in the 
House, and we have failed to act.
  I urge every member to educate themselves on the Lyme statistics in 
their home state and take a close look at H.R. 741.
  For those Members who sit on the Energy and Commerce Subcommittee on 
Health, I urge you to step forward and act to see that this bill is 
reported out of committee before the House completes its legislative 
business for the 110th Congress.
  For the House leadership, I urge that this bill be placed on the 
calendar now for action. If we can spend time loading up the suspension 
calendar and voting on commemorative anniversaries and naming post 
offices, we surely can find time to address legislation that can make a 
difference in the lives of Americans.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  I would just point out that on this and so many other issues it is 
amazing to me that the gentleman, who was in the majority for so many 
years and had so many opportunities to raise this and other issues, is 
somehow now suggesting that the Democrats are boxing it up. You know, 
Lyme has been around for a long time. The people concerned about this 
issue have been trying to address it for a long time. The bottom line, 
as the gentleman knows, it's a very controversial issue. We will 
certainly raise it, but he had ample opportunity, the many years that 
he was in the majority, to raise it and it just didn't happen.
  Mr. Speaker, I reserve the balance of my time.
  Mr. SULLIVAN. Mr. Speaker, may I inquire as to how much time is 
remaining?
  The SPEAKER pro tempore. The gentleman from Oklahoma has 8\1/2\ 
minutes remaining.
  Mr. SULLIVAN. Mr. Speaker, I yield as much time as he might consume 
to Mr. Wolf.
  Mr. WOLF. This is a growing issue. It is becoming a more important 
issue and a new issue. If you look at the statistics, it is growing 
around the Nation, it is now becoming an epidemic. And so, when I now 
see an epidemic taking place in my congressional district, in your 
congressional district, through New Jersey, through Connecticut--if you 
talk to Senator Dodd, he will tell you--through Massachusetts, all up 
and down the east coast, it is time to do something. And so I think it 
is time to deal with it.
  And I see the gentleman from New Jersey here. You have blocked this 
bill for a long period of time. And I will tell you, I will not permit 
you to block it. And next year, I will offer amendment after amendment 
after amendment and do whatever I can to make sure that people who are 
impacted by this, to make sure that people who do not even know what 
may very well be threatening them will not be threatened.
  I yield to the gentleman from New Jersey to also make some comments 
about this.
  Mr. SMITH of New Jersey. I thank my friend for yielding.
  Mr. Speaker, first of all, I want to thank Mr. Wolf for raising this. 
I didn't know he was going to be doing it; I just saw him on the 
television.
  Mr. WOLF. I didn't know I was going to be doing it until I saw the 
gentleman, Mr. Pallone, standing up and taking this up on suspension.
  Mr. SMITH of New Jersey. So I appreciate the gentleman yielding.
  Let me just say, to clarify the record, this legislation, which would 
seek to lay bare the science about Lyme disease, the fact that I 
believe we do have an epidemic, the fact that Lyme often go 
misdiagnosed, underdiagnosed. It is called ``the great pretender'' 
because so many people have it and don't know it. It often masquerades 
as other kinds of anomalies manifesting in a person's body. And it is 
not until it gets to a chronic state--very often causing severe 
disability, including neurological damage--that people finally realize 
that they have Lyme disease.
  There has been, unfortunately, a significant, I believe, cover up of 
the fact that chronic Lyme exists. The gentleman knows, we have asked 
him repeatedly, the gentleman from New Jersey, my good friend, Mr. 
Pallone, this legislation has been pending in his subcommittee. He told 
Pat Smith--no relation to me--who runs a Lyme disease association, that 
this would get a hearing and would be marked up. It has not been marked 
up. And meanwhile, this epidemic is growing--it is exploding.
  Now, let me just say for the enlightenment of my colleagues; the 
Infectious Disease Society of America,

[[Page H10174]]

which creates--and often does a very laudable job--the definitions, the 
parameters of what constitutes a certain disease, has looked at Lyme 
and said that chronic Lyme does not exist. Many of us have raised 
serious concerns about that because of what we believe to be conflicts 
of interest on the part of the panel members that made up the Lyme 
panel.
  I would note parenthetically that Chris Dodd is the prime sponsor of 
the comparison legislation that I've introduced on the House side. We 
have worked cooperatively on the legislation, so we have a companion 
bill on the Senate side. The legislation has over 110--I think it's 
112--cosponsors, totally bipartisan, Democrats and Republicans alike 
rallying around this legislation.
  The problem with the Infectious Disease Society of America is that 
these conflicts of interest, we believe, resulted in the conclusion 
that chronic Lyme doesn't exist. We don't know absolutely if that's the 
truth, but Attorney General Richard Blumenthal from Connecticut finally 
took a look at this and came back with a scathing insightful report 
that there were conflicts of interest. The red flag should go up 
everywhere.
  What does my legislation do? As Mr. Pallone knows, the legislation 
does not prescribe a protocol, as he has suggested. It simply calls for 
an advisory committee that would take a good, long look at Lyme disease 
and determine what is fact and fiction, and finally, for the sake of 
all of those who are suffering immensely from this disease and their 
families, say what we need to be doing to mitigate and hopefully stop 
the spread of Lyme, whether it be long-term and very heavy antibiotic 
treatment--which I believe probably is the case based on clinical 
practitioners who have suggested that to be the case--but we want an 
honest look.
  As Mr. Pallone knows, we did not get an honest look from the 
Infectious Disease Society of America. And I find that appalling. 
Conflict of interest with insurance companies has no place in modern 
medicine. And regrettably, and it has been--again, the full weight of 
the Attorney General's report clearly suggests, Richard Blumenthal of 
Connecticut, that there were significant conflicts of interest on the 
part of the panel members.
  Our legislation says let's go where the science takes us. If the 
science says chronic Lyme exists, then all those patients and the 
insurance companies which need to be providing the coverage, to get the 
medicines and the like, like antibiotics--because what has happened, as 
my friend knows, because of this exclusion of chronic Lyme due to a 
problem in definition, the insurance companies say we don't have to 
pay. So when a patient presents with a bill of $100,000 or some 
excessive amount of money, the insurance companies say, not us, tough 
luck, we're not going to pay for it. And they go right back to what I 
believe to be a false definition that precludes chronic Lyme as a 
condition.
  Now, you might think that chronic Lyme doesn't exist, I say to my 
friend, the chairman, but let's go where the science takes us. We need 
this advisory committee and we need it now. All points of view, as our 
legislation clearly suggests, has to be a part of this group. We want a 
robust debate, not something that is engineered by insurance companies.
  Finally, the legislation would authorize $100 million over 5 years, 
$20 million each year. Frankly, if that drops off due to opposition to 
new authorization, and is only an authorization, I would like to see it 
go forward nevertheless, know this however, we're not spending enough 
on Lyme.
  And Lyme is, as Mr. Wolf said so aptly, growing exponentially. CDC 
admits we are missing most of the cases. As many as 90 percent of the 
cases go unreported. Our state, Mr. Pallone, as you know, is number 
three in prevalence according to CDC numbers, and even that is probably 
very much understated in terms of the actual prevalence of Lyme 
disease.
  So I would make the appeal again, as I have made to my friend from 
New Jersey, as I have made to Mr. Dingell, as I have made to Mr. Barton 
and everyone else, this legislation ought to be on this floor and it 
ought to be on the floor today. It is truly bipartisan. There ought to 
be a consensus to go where the science takes us. And again, an advisory 
committee, a Blue Ribbon panel that would be configured under this 
legislation would finally end, hopefully, this contentious debate and 
tell us what it is and what it is not.
  I have known dozens of people who have had chronic Lyme. Now, you 
might say it doesn't exist, the Infectious Disease Society says it 
doesn't exist. These victims suffer from the spirochete, and have 
suffered neurological damage, severe joint damage, and many, many other 
problems.
  There is a new book called ``Cure Unknown'' that I would recommend to 
the House. I read it in one sitting because it is so incisive in 
finally breaking through the fog on this disease. People are walking 
around with Lyme and they don't even know it.
  We need to bring the forces to bear of the U.S. Government that an 
advisory committee of this kind would do a Blue Ribbon panel, a 9/11-
type panel of scientists, of the best people we can put together to 
say, put aside the egregiously flawed Infectious Diseases Society of 
America's finding, which Blumenthal said was riddled with conflict of 
interest--and I urge Members to read Blumenthal's opinion, I will put 
it in the Record so Members can read it--his findings were, 
``atrocious, conflict of interest everywhere.''
  This legislation ought to be on the floor and it ought to be on the 
floor today.


                               Office of the Attorney General,

                               Hartford, Connecticut, May 1, 2008.

Attorney General's Investigation Reveals Flawed Lyme Disease Guideline 
   Process, IDSA Agrees To Reassess Guidelines, Install Independent 
                                Arbiter

       Attorney General Richard Blumenthal today announced that 
     his antitrust investigation has uncovered serious flaws in 
     the Infectious Diseases Society of America's (IDSA) process 
     for writing its 2006 Lyme disease guidelines and the IDSA has 
     agreed to reassess them with the assistance of an outside 
     arbiter.
       The IDSA guidelines have sweeping and significant impacts 
     on Lyme disease medical care. They are commonly applied by 
     nsurance companies in restricting coverage for long-term 
     antibiotic treatment or other medical care and also strongly 
     influence physician treatment decisions.
       Insurance companies have denied coverage for long-term 
     antibiotic treatment relying on these guidelines as 
     justification. The guidelines are also widely cited for 
     conclusions that chronic Lyme disease is nonexistent.
       ``This agreement vindicates my investigation--finding 
     undisclosed financial interests and forcing a reassessment of 
     IDSA guidelines,'' Blumenthal said. ``My office uncovered 
     undisclosed financial interests held by several of the most 
     powerful IDSA panelists. The IDSA's guideline panel 
     improperly ignored or minimized consideration of alternative 
     medical opinion and evidence regarding chronic Lyme disease, 
     potentially raising serious questions about whether the 
     recommendations reflected all relevant science.
       ``The IDSA's Lyme guideline process lacked important 
     procedural safeguards requiring complete reevaluation of the 
     2006 Lyme disease guidelines--in effect a comprehensive 
     reassessment through a new panel. The new panel will accept 
     and analyze all evidence, including divergent opinion. An 
     independent neutral ombudsman--expert in medical ethics and 
     conflicts of interest, selected by both the IDSA and my 
     office--will assess the new panel for conflicts of interests 
     and ensure its integrity.''
       Blumenthal's findings include the following: The IDSA 
     failed to conduct a conflicts of interest review for any of 
     the panelists prior to their appointment to the 2006 Lyme 
     disease guideline panel;
       Subsequent disclosures demonstrate that several of the 2006 
     Lyme disease panelists had conflicts of interest;
       The IDSA failed to follow its own procedures for appointing 
     the 2006 panel chairman and members, enabling the chairman, 
     who held a bias regarding the existence of chronic Lyme, to 
     handpick a likeminded panel without scrutiny by or formal 
     approval of the IDSA's oversight committee;
       The IDSA's 2000 and 2006 Lyme disease panels refused to 
     accept or meaningfully consider information regarding the 
     existence of chronic Lyme disease, once removing a panelist 
     from the 2000 panel who dissented from the group's position 
     on chronic Lyme disease to achieve ``consensus'';
       The IDSA blocked appointment of scientists and physicians 
     with divergent views on chronic Lyme who sought to serve on 
     the 2006 guidelines panel by informing them that the panel 
     was fully staffed, even though it was later expanded;
       The IDSA portrayed another medical association's Lyme 
     disease guidelines as corroborating its own when it knew that 
     the two panels shared several authors, including the chairmen 
     of both groups, and were working on guidelines at the same 
     time. In allowing its panelists to serve on both groups at 
     the same time, IDSA violated its own conflicts of interest 
     policy.

[[Page H10175]]

       IDSA has reached an agreement with Blumenthal's office 
     calling for creation of a review panel to thoroughly 
     scrutinize the 2006 Lyme disease guidelines and update or 
     revise them if necessary. The panel--comprised of individuals 
     without conflicts of interest--will comprehensively review 
     medical and scientific evidence and hold a scientific hearing 
     to provide a forum for additional evidence. It will then 
     determine whether each recommendation in 2006 Lyme disease 
     guidelines is justified by the evidence or needs revision or 
     updating.
       Blumenthal added, ``The IDSA's 2006 Lyme disease guideline 
     panel undercut its credibility by allowing individuals with 
     financial interests--in drug companies, Lyme disease 
     diagnostic tests, patents and consulting arrangements with 
     insurance companies--to exclude divergent medical evidence 
     and opinion. In today's healthcare system, clinical practice 
     guidelines have tremendous influence on the marketing of 
     medical services and products, insurance reimbursements and 
     treatment decisions. As a result, medical societies that 
     publish such guidelines have a legal and moral duty to use 
     exacting safeguards and scientific standards.
       ``Our investigation was always about the IDSA's guidelines 
     process--not the science. IDSA should be recognized for its 
     cooperation and agreement to address the serious concerns 
     raised by my office. Our agreement with IDSA ensures that a 
     new, conflicts-free panel will collect and review all 
     pertinent information, reassess each recommendation and make 
     necessary changes.
       ``This Action Plan--incorporating a conflicts screen by an 
     independent neutral expert and a public hearing to receive 
     additional evidence--can serve as a model for all medical 
     organizations and societies that publish medical guidelines. 
     This review should strengthen the public's confidence in such 
     critical standards.''


                      THE GUIDELINE REVIEW PROCESS

       Under its agreement with the Attorney General's Office, the 
     IDSA will create a review panel of eight to 12 members, none 
     of who served on the 2006 IDSA guideline panel. The IDSA must 
     conduct an open application process and consider all 
     applicants.
       The agreement calls for the ombudsman selected by 
     Blumenthal's office and the IDSA to ensure that the review 
     panel and its chairperson are free of conflicts of interest.
       Blumenthal and IDSA agreed to appoint Dr. Howard A. Brody 
     as the ombudsman. Dr. Brody is a recognized expert and author 
     on medical ethics and conflicts of interest and the director 
     of the Institute for Medical Humanities at the University of 
     Texas Medical Branch. Brody authored the book, ``Hooked: 
     Ethics, the Medical Profession and the Pharmaceutical 
     Industry.''
       To assure that the review panel obtains divergent 
     information, the panel will conduct an open scientific 
     hearing at which it will hear scientific and medical 
     presentations from interested parties. The agreement requires 
     the hearing to be broadcast live to the public on the 
     Internet via the IDSA's website. The Attorney General's 
     Office, Dr. Brody and the review panel will together finalize 
     the list of presenters at the hearing.
       Once it has collected information from its review and open 
     hearing, the panel will assess the information and determine 
     whether the data and evidence supports each of the 
     recommendations in the 2006 Lyme disease guidelines.
       The panel will then vote on each recommendation in the 
     IDSA's 2006 Lyme disease guidelines on whether it is 
     supported by the scientific evidence. At least 75 percent of 
     panel members must vote to sustain each recommendation or it 
     will be revised.
       Once the panel has acted on each recommendation, it will 
     have three options: make no changes, modify the guidelines in 
     part or replace them entirely.
       The panel's final report will be published on the IDSA's 
     website.


           ADDITIONAL FINDINGS OF BLUMENTHAL'S INVESTIGATION

       IDSA convened panels in 2000 and 2006 to research and 
     publish guidelines for the diagnosis and treatment of Lyme 
     disease. Blumenthal's office found that the IDSA disregarded 
     a 2000 panel member who argued that chronic and persistent 
     Lyme disease exists. The 2000 panel pressured the panelist to 
     conform to the group consensus and removed him as an author 
     when he refused.
       IDSA sought to portray a second set of Lyme disease 
     guidelines issued by the American Academy of Neurology (AAN) 
     as independently corroborating its findings. In fact, IDSA 
     knew that the two panels shared key members, including the 
     respective panel chairmen and were working on both sets of 
     guidelines at the same time--a violation of IDSA's conflicts 
     of interest policy.
       The resulting IDSA and AAN guidelines not only reached the 
     same conclusions regarding the non-existence of chronic Lyme 
     disease, their reasoning at times used strikingly similar 
     language. Both entities, for example, dubbed symptoms 
     persisting after treatment ``Post-Lyme Syndrome'' and defined 
     it the same way.
       When IDSA learned of the improper links between its panel 
     and the AAN's panel, instead of enforcing its conflict of 
     interest policy, it aggressively sought the AAN's endorsement 
     to ``strengthen'' its guidelines' impact. The AAN panel--
     particularly members who also served on the IDSA panel--
     worked equally hard to win AAN's backing of IDSA's 
     conclusions.
       The two entities sought to portray each other's guidelines 
     as separate and independent when the facts call into question 
     that contention.
       The IDSA subsequently cited AAN's supposed independent 
     corroboration of its findings as part of its attempts to 
     defeat federal legislation to create a Lyme disease advisory 
     committee and state legislation supporting antibiotic therapy 
     for chronic Lyme disease.
       In a step that the British Medical Journal deemed 
     ``unusual,'' the IDSA included in its Lyme guidelines a 
     statement calling them ``voluntary'' with ``the ultimate 
     determination of their application to be made by the 
     physician in light of each patient's individual 
     circumstances.'' In fact, United Healthcare, Health Net, Blue 
     Cross of California, Kaiser Foundation Health Plan and other 
     insurers have used the guidelines as justification to deny 
     reimbursement for long-term antibiotic treatment.
       Blumenthal thanked members of his office who worked on the 
     investigation--Assistant Attorney General Thomas Ryan, former 
     Assistant Attorney General Steven Rutstein and Paralegal 
     Lorraine Measer under the direction of Assistant Attorney 
     General Michael Cole, Chief of the Attorney General's 
     Antitrust Department.

                                    Congress of the United States,
                                     Washington, DC, May 18, 2007.
     Hon. Frank Pallone, Jr.,
     Chairman, Subcommittee on Health, House Committee on Energy 
         and Commerce, Washington, DC.
       Dear Chairman Pallone: As co-chairs of the congressional 
     L.yme Disease Caucus, we are writing to respectfully request 
     that you mark-up and report H.R. 741 or find a suitable 
     legislative vehicle to attach significant provisions of this 
     desperately needed legislation.
       H.R. 741, the ``Lyme and Tick-borne Disease Prevention, 
     Education, and Research Act of 2007,'' would work toward 
     goals for the prevention, accurate diagnosis, and effective 
     treatment of Lyme disease and would authorize an increase in 
     total research and education funding of $20 million per year 
     over 5 years. The bill contains numerous measures to help 
     ensure that resources are expended effectively to provide the 
     most benefit to people with Lyme and other tick-borne 
     diseases.
       Introduced in January, this legislation currently has 77 
     bipartisan co-sponsors. It is supported by more than 60 Lyme 
     disease organizations across the country. This legislation 
     holds the promise to significantly improve the lives of the 
     large numbers of Americans living with Lyme, as well as other 
     tick-borne diseases, and their families and friends.
       Lyme is the most prevalent vector-borne disease in the 
     United States today. More than 220,000 Americans develop Lyme 
     each year. According to the Centers for Disease Control & 
     Prevention (CDC), only 10 percent of cases that meet its 
     surveillance criteria are reported. Cases that fall outside 
     the surveillance criteria are not even considered anywhere 
     statistically.
       If not diagnosed and treated early, Lyme disease can lead 
     to chronic illness and can affect every system in the body, 
     including the central nervous system and cardiac systems. 
     Later symptoms of Lyme disease include arthritis, 
     neurological problems, such as facial paralysis, 
     encephalopathy, memory problems, weakness of the extremities, 
     seizures, heart block and inflammation of the heart muscle, 
     and even blindness.
       In recent years, Lyme disease has continued an upward trend 
     in endemic areas and also has expanded into more areas. 
     Reported Lyme cases increase, by 100 percent from 1992 to 
     2004 according to CDC. Currently, all states except Montana 
     have reported cases of Lyme disease. It even has been 
     reported that Montana residents have gone outside of the 
     State and tested positive for Lyme). It is far more common 
     than all other insect-borne diseases. Now other diseases 
     are being carried by the same ticks: babesiosis, 
     naplasmosis, encephalitis, perhaps bartonelliosis.
       While the emergence of Lyme disease in the Northeastern and 
     mid-Atlantic states has been linked to reforestation, climate 
     change also is an infuencing factor. According to a November 
     2005 report by the Center for Health and the Global 
     Environment at the Harvard Medical School, ``Climate Change 
     Futures: Health Ecological and Economic Dimensions,'' Lyme 
     disease is spreading in North America and Europe as winters 
     warm, . . ..'' In areas where Lyme disease is already 
     present, warming temperatures may increase the density of 
     ticks by increasing off-host survival.
       Over the past decade and with the increase in Lyme cases, 
     problems with diagnosis and treatment of Lyme disease have 
     become much more visible--affecting larger numbers of people 
     over longer periods of time. We have become increasing 
     concerned with reports of patients who go long periods of 
     time before getting a definitive diagnosis due to the lack of 
     a gold standard diagnostic test and who received delayed or 
     inappropriate treatment because of the lack of treating 
     physicians nationwide and lack of physician education. Many 
     patients lose their jobs and must apply for disability.
       In consideration of these conditions the Federal investment 
     in Lyme is surprisingly small--$5.4 million at CDC and $24 
     million at NIH in FY 2006, actual reductions at both agencies 
     since 2004. While funding levels are a means to an end, the 
     ultimate goal is to put an end to patients having their 
     illnesses and disabilities greatly exacerbated by the lack of 
     accurate diagnostics and effective

[[Page H10176]]

     treatments. H.R. 741 addresses this goal by directing HHS to 
     work toward development of a sensitive and accurate 
     diagnostic test improved surveillance and prevention and 
     clinical outcomes research to determine the long-term course 
     of illness and the effectiveness of treatments. In addition, 
     the bill would establish a Tick-Borne Disease Advisory 
     Committee to ensure communication and coordination among 
     federal agencies, medical professionals, and patients/patient 
     advocates. The Lyme conmunity has been seeking this voice for 
     a decade.
       As Chairman of the Energy and Commerce Committee, we know 
     that you share our commitment to significantly improve the 
     health outlook for all citizens of this country, including 
     the hundreds of thousands of Americans who have experienced 
     or will experience the too common occurrence of being bitten 
     by Ivodes scapularis, the deer tick or black legged tick, and 
     contracting Lyme disease. Now Amblvomma americanum, the lone 
     star tick, is rapidly spreading throughout the country from 
     its former more southern habitat, and states in the northeast 
     are beginning to feel its impact as it spreads STARI, a Lyme 
     like illness with the same symptoms as Lyme disease. It also 
     carries Ehrliehiosis or tularemia. Scientists are saying that 
     this lone star is aggressive and will pursue people from 30 
     feet away, not like the deer tick which wants for its prey 
     sitting on vegetation.
       To enure that these necessary goals are not lost, we 
     respectfully request that you shcedule for a mark-up the Lyme 
     and tick-borne Disease Prevention, Education, and Research 
     Act of 2007 H.R. 741. If you have any questions on this 
     matter, please do not hesitate to contact us.
           Sincerely,
     Christopher H. Smith,
       Member of Congress.
     Tim Holden,
       Member of Congress.
  The SPEAKER pro tempore. All time from the gentleman from Oklahoma 
has expired.
  The gentleman from New Jersey has 16 minutes remaining.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I might 
consume.
  First of all, I want to say to the gentleman from New Jersey, he has 
made a lot of statements about my views on this subject which are 
simply not true, and I do not appreciate them.
  Mr. SMITH of New Jersey. Will the gentleman yield?
  Mr. PALLONE. Mr. Speaker, I have no intention of yielding to the 
gentleman because of the disrespect that he has shown.
  Now, secondly, let me also say this: I do appreciate the fact that 
the gentleman from Virginia (Mr. Wolf) has, on several occasions, come 
up to me in the last few months and talked to me about this 
legislation. And we've had very reasoned conversations about the 
legislation. But I will also point out that the gentleman from New 
Jersey has not. The gentleman from New Jersey has not spoken to me at 
all about this legislation, and certainly not, in my recollection, in 
the last year. So if he felt it was so important, the way the gentleman 
from Virginia did, and has, he certainly had many opportunities to come 
up to me and talk to me about it. He has not. And I see the gentleman 
from New Jersey all the time--on the floor, at home, on various 
occasions. He has not spoken to me.
  So I want to thank the gentleman from Virginia for at least saying 
that he has taken the time, had some reasoned discussions about it. 
That is not true of my colleague from New Jersey, which is why I deeply 
resent the fact that he's on the floor here today talking about it 
because it is the first time I recollect him ever talking to me about 
it.
  Now, let me say a few other things. First of all, as far as the 
science is concerned, the science is in the Infectious Diseases Society 
and the CDC, not with the Attorney General and some political 
grandstanding that he's doing in Connecticut, nor with my colleague 
from New Jersey who is grandstanding here today.
  I am very concerned about Lyme disease. I have been working with the 
CDC to address the issue. We are awaiting answers from the agency on 
how best to address this. I have, in fact, talked to many of my 
constituents about this, even though my own colleague hasn't talked to 
me about it from New Jersey.
  And I also would like to say this: As far as the Infectious Diseases 
Association, they basically are the majority opinion. Many doctors, 
including my neighbors who are physicians in my hometown, very much 
agree with the Infectious Diseases Society and don't think that this 
should be treated with these antibiotics for a long period of time 
because they're concerned about the impact on people and whether they 
would be seriously injured or even die from the antibiotics.
  There is a lot of controversy that involves this issue. It is very 
involved and it is very controversial. It shouldn't be considered today 
on a consent calendar. And that was the only point I was trying to make 
for my colleague from Virginia, that we need to have hearings. And we 
will have hearings on the issue in general, and we can include this 
bill as part of that in the next session. But to bring this up today on 
the consent calendar when they know very well that there is not 
agreement on this and we couldn't possibly get a UC or have this on the 
suspension calendar, it's really very upsetting, and particularly 
coming from my colleague from New Jersey, who has never talked to me 
about this at all.
  Mr. DINGELL. Mr. Speaker, I support S. 3560, the ``QI Supplemental 
Funding Act of 2008''. The Qualified Individuals Program (QI) is a 
program within Medicaid that helps low-income seniors and individuals 
with disabilities pay their Medicare Part B premium. The Medicare 
Improvements for Patients and Providers Act of 2008 extended the 
funding for the QI program through December 2009.
  Projections, however, regarding the amount of funding necessary to 
ensure continuation of this program through next year were incorrect. 
Without Congressional action to add an additional $45 million to the QI 
program, seniors and individuals with disabilities who have an income 
as low as $12,500 will be in jeopardy of losing this needed assistance.
  The cost of this provision is fully offset with a provision that 
requires States to improve their Medicaid eligibility determinations by 
using the Public Assistance Reporting Information System (PARIS) 
interstate match. PARIS helps States share information regarding public 
assistance programs, such as Temporary Assistance for Needy Families 
(TANF), Food Stamps, and Medicaid, to identify individuals or families 
who may be receiving benefit payments in more than one State.
  Similarly, S. 3560 includes a clarification to ensure that the 
Medicaid Integrity Program created in the Deficit Reduction Act of 
2005, to operate as intended. The Medicaid Integrity Program performs 
audits and educates providers, Federal and State employees, and others 
on payment integrity and quality of care initiatives. The provision 
would allow for Federal reimbursement of state employees for these 
program integrity initiatives.
  Finally, this package includes a provision which states that any 
antibiotic that was the subject of an application submitted to the Food 
and Drug Administration, but was not approved, can get the three-year 
and/or five-year ``Hatch/Waxman exclusivity'' or a patent term 
extension.
  I urge all my colleagues in the House to vote in favor of S. 3560.
  Mr. PALLONE. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the Senate bill, S. 3560.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the Senate bill was passed.
  A motion to reconsider was laid on the table.

                          ____________________